白芍总苷胶囊联合羟氯喹治疗干燥综合征临床疗效的系统评价

Systematic Review of the Clinical Efficacy of Paeonia lactiflora Total Glucosides Capsule Combined with Hydroxychloroquine in the Treatment of Sjogren’s Syndrome

目的:系统评价白芍总苷胶囊联合羟氯喹对比单纯使用羟氯喹治疗干燥综合征的临床疗效,以期为临床治疗提供循证学支持。方法:计算机检索PubMed、中国生物医学文献数据库、中国知网、万方数据库和维普数据库等,收集白芍总苷胶囊联合羟氯喹(研究组)对比单纯使用羟氯喹(对照组)治疗干燥综合征的随机对照试验,对符合纳入标准的临床研究进行资料提取和质量评价后,采用RevMan 5.3统计软件进行Meta分析。结果:共纳入10项随机对照试验,包括731例患者。分析结果表明,研究组患者在总有效率(RR=1.33,95%CI=1.23~1.44,P<0.000 01)、红细胞沉降率(MD=-8.00,95%CI=-12.07~-3.93,P=0.000 1)、唾液腺流率(MD=0.03,95%CI=0.02~0.04,P<0.000 01)、唾液流量(SMD=-1.09,95%CI=-1.52~-0.65,P<0.000 01)、Schirmer试验结果(MD=2.69,95%CI=1.19~4.19,P=0.000 4)和免疫球蛋白G水平(MD=-3.25,95%CI=-4.06~-2.44,P<0.000 01)等方面优于对照组,差异均有统计学意义;两组患者不良反应发生率比较,差异无统计学意义(OR=1.44,95%CI=0.73~2.84,P=0.29)。结论:现有临床研究证据表明,白芍总苷胶囊联合羟氯喹治疗干燥综合征的总有效率和实验室指标水平优于单纯使用羟氯喹,且安全性与单纯使用羟氯喹相当。

OBJECTIVE: To systematically review the clinical efficacy of Paeonia lactiflora total glucosides capsule combined with hydroxychloroquine in the treatment of Sjogren’s syndrome, in order to provide evidence-based support for clinical treatment. METHODS:PubMed, CBM, CNKI, Wanfang Data, VIP and other databases were searched by computer to collect randomized controlled trials(RCTs) about P. lactiflora total glucosides capsule combined with hydroxychloroquine(study group) versus hydroxychloroquine alone(control group) in the treatment of Sjogren’s syndrome. After data extraction and quality evaluation of included studies that met the inclusion criteria, RevMan 5.3 statistical software was used to perform meta-analysis. RESULTS:A total of 10 RCTs were included, involving 731 patients. The analysis showed that study group was better than control group in terms of overall effective rate(RR=1.33,95%CI=1.23-1.44,P<0.000 01), erythrocyte sedimentation rate(MD=-8.00,95%CI=-12.07--3.93,P=0.000 1), flow rate of salivary gland(MD=0.03,95%CI=0.02-0.04,P<0.000 01), salivary flow(SMD=-1.09,95%CI=-1.52--0.65,P<0.000 01), results of Schirmer test(MD=2.69,95%CI=1.19-4.19,P=0.000 4) and IgG level(MD=-3.25,95%CI=-4.06--2.44,P<0.000 01), with statistically significant difference;but there was no statistical significance in the incidence of adverse drug reaction between two groups(OR=1.44,95%CI=0.73-2.84,P=0.29). CONCLUSIONS:Existing clinical studies have shown that total effective rate and laboratory indicators of P. lactiflora total glucosides capsule combined with hydroxychloroquine in the treatment of Sjogren’s syndrome are better than those of hydroxychloroquine alone, but its safety is equivalent to hydroxychloroquine alone.